FDA to fine cord blood banks for exaggerations

NO GUARANTEES:The administration said cord blood banking facilities must not make any promises involving procedures expected to be developed in the future

By Alison Hsiao / Staff reporter

Private umbilical cord blood banks making exaggerated medical promises face stiff fines, the Food and Drug Administration (FDA) said yesterday in response to a recent case of the mother of a paralyzed child accusing a private cord blood bank of leading her to believe that spinal surgery using the cord blood was a viable cure for her daughter.

The mother had stored the cord blood of her three-year-old daughter Hsun-hsun, who has tetraplegia, at the cost of NT$75,000 three years ago.

However, when the mother asked a hospital to perform an operation using stem cells derived from umbilical cord blood, the hospital said that the operation would be the nation’s first so the permission of the Ministry of Health and Welfare was needed.

However, the surgery did not gain approval from the health authorities, who said that it would be illegal and the hospital was not technologically advanced enough to perform such a procedure.

Hsun-hsun’s mother was outraged and accused the salesperson of the cord blood bank of overstating the effectiveness of cord blood and deceiving consumers.

“I paid the bank to store the cord blood hoping that my child would be able to use it someday if she needed it. If it is not usable, why does the government allow [private blood banks] to sell such services?” she said.

The FDA said that under current regulations, cord blood banking facilities must not make any promises about procedures involving cord blood expected to be developed in the future.

As for the reports by local media saying that some cord blood salespeople had made false claims about 3D printing of human organs in five to 10 years or having the ability to make eight bags of cord blood out of one, the FDA said that the company would be subject to a fine of up to NT$500,000 in accordance with the Regulations for Administration on Human Organ Bank (人體器官保存庫管理辦法) and the Organ Transplant Act (人體器官移植條例).

The Consumer Protection Act (消費者保護法) and the Fair Trade Act (公平交易法) might also apply if the violations are reported to the relevant authorities by the consumers, the administration said.

However, the government might be able to do more than just fining the companies or reining in their claims.

Mark Liu (劉宏恩), a law professor at National Chengchi University specializing in biomedical ethics, has a different take on the incident.

Describing the commercialization of cord blood banking in Taiwan as “going beyond the pale,” Liu said the lesson that should be drawn from the incident is the point mentioned by the mother on the uselessness of the privately banked cord blood.

Liu said the government was ignoring the fact that many European countries have either restricted or banned the commercialization of cord blood banking and that Japan has only public cord blood banks.

“Cord blood can be matched to different people, which is to say that, just as my cord blood might help save somebody else’s life, my life can be saved by somebody else’s cord blood. So the idea of just storing my own blood for my own use doesn’t make sense at all,” Liu said, adding that according to the US’ National Institutes of Health, the odds of successfully using a person’s own cord blood for medical procedures in his or her lifetime may be as low as one in 200,000.